Jane Seymour Oil-Free Tinted Moisturizer with SPF 55

Dosage form: liquid
Ingredients: Oxybenzone 60uL in 1mL, Octocrylene 20uL in 1mL, Octisalate 50uL in 1mL, Avobenzone 30uL in 1mL, Homosalate 100uL in 1mL
Labeler: Guthy-Renker, LLC.
NDC Code: 11410-412

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DIRECTIONS:

Apply to face every morning after cleansing.

ACTIVE INGREDIENTS:

Oxybenzone 6.0%, Octocrylene 2.0%, Octisalate 5.0%, Avobenzone 3.0%, Homosalate 10.0%

INACTIVE INGREDIENTS:

Water, Butylene Glycol, PEG-8, Poly-Ethylene, Silica, Dimethicone, Picea Excelsa Wood Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Methyl Glucose Sesquistearate, Glycerin, Acrylates/C10-30 Alkyl Acrylates Cross-Polymer, Bentonite, Sodium Hydroxide, Sodium Polyacrylate, Disodium EDTA, Xanthan Gum, Ammonium Poly-Acrylate, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin, Alumina, Iron oxides (C.I. 77492), Titanium Dioxide, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77499)

Distributed by: Guthy-Renker®, LLC
P.O. Box 14383
Palm Desert, CA 92255-4383
London UK SW1Y 4HH,
Sydney, Australia 2138,
Auckland, New Zealand,
Toronto, Ontario M1X 1E7

M050903
ND.0076

Principal Display Panel – 30 mL Tube

Natural

Advantage®

Jane Seymour

Oil-Free

Tinted

Moisturizer

With SPF 55

1 fl oz 30 ml e

JANE SEYMOUR OIL-FREE TINTED MOISTURIZER WITH SPF 55 
oxybenzone, octocrylene, octisalate, avobenzone, homosalate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-412
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxybenzone (Oxybenzone) Oxybenzone60 uL  in 1 mL
Octocrylene (Octocrylene) Octocrylene20 uL  in 1 mL
Octisalate (Octisalate) Octisalate50 uL  in 1 mL
Avobenzone (Avobenzone) Avobenzone30 uL  in 1 mL
Homosalate (Homosalate) Homosalate100 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
POLYETHYLENE GLYCOL 400 
SILICON DIOXIDE 
DIMETHICONE 
PICEA ABIES WOOD 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
SODIUM ASCORBYL PHOSPHATE 
VITAMIN A PALMITATE 
TOCOPHEROL 
GLYCERIN 
CARBOMER COPOLYMER TYPE A 
BENTONITE 
SODIUM HYDROXIDE 
SODIUM POLYACRYLATE (8000 MW) 
EDETATE DISODIUM 
XANTHAN GUM 
PHENOXYETHANOL 
CHLORPHENESIN 
ETHYLHEXYLGLYCERIN 
ALUMINUM OXIDE 
FERRIC OXIDE YELLOW 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:11410-412-0130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/04/2011
Labeler - Guthy-Renker, LLC. (608315453)
Registrant - AMCOL Health & Beauty Solutions, Incorporated (872684803)
Establishment
NameAddressID/FEIOperations
AMCOL Health & Beauty Solutions, Incorporated872684803MANUFACTURE
Establishment
NameAddressID/FEIOperations
Thibiant, International, Inc.083913913MANUFACTURE

Revised: 11/2011
 
Guthy-Renker, LLC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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